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NCT00997984 · ClinicalTrials.gov registry record · Phase 3
Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study)
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 340
- Enrollment target
NCT00997984 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 340 participants.
The verdict
NCT00997984, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 340 participants
- Enrollment target
Study Summary
The primary purpose is to assess the efficacy of once daily dosing with optimized SPD503 (1, 2, 3 and 4mg/day), dosed either in the morning or evening, compared to placebo, in children with ADHD as measured by change from baseline score at endpoint on the ADHD-RS-IV.
Interventions
- DRUG placebo
- DRUG extended-release guanfacine hydrochloride (SPD503)
- DRUG extended-release guanfacine hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 340 participants |
| Start Date | 2009-11-17 |
| Est. Completion | 2010-10-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00997984
The ClinicalTrials.gov registry entry for NCT00997984 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 340 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT00997984 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00997984 about?
NCT00997984 is a clinical study titled "Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study)". The primary purpose is to assess the efficacy of once daily dosing with optimized SPD503 (1, 2, 3 and 4mg/day), dosed either in the morning or evening, compared to placebo, in children with ADHD as measured by change from baseline score at endpoint on the ADHD-RS-IV.
What is the current status of trial NCT00997984?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 340 participants. The study started on 2009-11-17. Estimated completion is 2010-10-09.
What interventions are being tested in trial NCT00997984?
The interventions under investigation include: placebo (DRUG), extended-release guanfacine hydrochloride (SPD503) (DRUG), extended-release guanfacine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00997984?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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